Healthy volunteers
Conditions
Interventions
Rosuvastatin 5mg is administered once on Day 1 of Phase 1 and Day 1 of Phase 2 Study
Digoxin 0,25mg on Day 1 of the Phase 2 study.
Sponsors
Dept of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Sato Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Subjects who are aged between 20 and 45 (exclusive) years old, at the time of Informed Consent. 2) Subjects who have a BMI (Body Mass Index) between 18.5 and 28.0 (exclusive).
Exclusion criteria
Exclusion criteria: 1) Have a history of drug abuse or alcohol addiction or a history of allergies to any medication. 2) Have a history of hypersensitivity to rosuvastatin or digoxin . 3) Have a disease which may affect drug evaluation, a history of invasive therapy or radiation therapy. 4) Have taken the drugs, foods or drinks containing methylxanthine such as caffeine (coffee, tea, cola drinks, chocolate, etc) for 48 hours before testing. 5) Have taken any foods or drinks containing grapefruit juice, grapefruit, St. John's wort or Seville orange for 48 hours before testing. 6) Smoke (including those who take nicotine - containing products). However, those who stop smoking (unused period of nicotine-containing products) over 24 weeks are excluded. 7) Drink any beverage containing alcohol for 1 weeks before testing. 8) Conducted intense exercise or hard labor (more than 1 day a day for more than 5 days a week). 9) Have a history of drug abuse or alcohol addiction. 10) Use any medical drugs for 4 weeks before testing. 11) Treated with OTC, nutrients, vitamins, herbal preparations (including traditional Chinese medicine) for 1 weeks before testing. 12) Subjects are not currently enrolled in a clinical trial involving an investigational drug or device, or had not been enrolled in any other medical research for 16 weeks before testing. 13) Fall under any of the following: a) Received blood transfusion within 12 weeks before testing. b) Donated more than 400 mL of blood within 12 weeks before testing. c) Donated more than 200 mL of blood within 4 weeks before testing. d) Donated component blood donation within 2 weeks before testing. 14) Have a history of infectious diseases requiring urgent treatment. 15) Have a positive result for Human Immunodeficiency Virus (HIV) test, hepatitis B or C antigen test or syphilis test. 16) Subjects determined by the investigators to be inadequate for inclusion in this study for any other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compared between a rosuvastatin alone and rosuvastatin with digoxin by means of the geometric mean ratio (GMR) AUC (0-last) and its 90% confidence interval (CI). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Cmax and GMR (AUC (0-inf)) and its 90% CI 2) Pharmacokinetic parameter (Cmax, tmax, t1/2, AUC0-inf, AUC0-last, CL/F, Vd/F) 3) Plasma concentration of rosuvastatin in transition | — |
Countries
Japan
Contacts
Public ContactNaoto Uemura
Oita University Hospital Clinical Pharmacology Center
Outcome results
None listed